Excellence in Oncology Clinical Trials

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Excellence in Oncology Clinical Trials"

Transcription

1 Oncology Clinical Trials We work to find a better way. We work to raise standards and deliver more. We break new ground to make progress possible.

2 Oncology Research ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development from compound selection to Phase I-IV clinical studies. Despite significant advances in oncology research, one in every eight deaths worldwide is still caused by cancer. In some developed nations, cancer has overtaken heart disease as the top killer of people under the age of 85. And while heart disease continues to be the leading cause of death for those over 85 in the U.S., that trend is expected to reverse within ten years, according to leading American medical authorities, making cancer the number one cause of death in the United States by With over 12 million new cases diagnosed in 2007 alone and 7.6 million deaths - there is no doubt that cancer is and will continue to be - one of the biggest challenges facing the research community. 2 References: 1. Global Cancer Facts and Figures, American Cancer Society, ibid 3. Global Cancer Facts and Figures, American Cancer Society, 2007 Cancer deaths on the rise 3 Cancer accounts for 7.6 million (or 13%) of all deaths worldwide. By 2015 the total number of cancer deaths per year is estimated to be 9 million. Lung (1.3 million) Stomach (1 million) Liver (662,000) Colon (655,000) Breast (502,000) Source: American Cancer Society 2007 Our global services are offered through the expertise of our five international divisions. Top 12 Pharmaceutical & Biotechnology Companies Oncology Pipeline * GLAXOSMITHKLINE (GSK) # of Oncology Drugs 509 Central Laboratories PFIZER, INC. SANOFI-AVENTIS Clinical Research Contracting Solutions Development Solutions NOVARTIS AG (NOVARTIS PHARMACEUTICALS) ASTRAZENECA HOFFMANN-LA ROCHE, INC. MERCK & CO., INC. BRISTOL-MEYERS SQUIBB COMPANY Medical Imaging AMGEN, INC. WYETH GENENTECH, INC. 117 CELGENE CORPORATION) * Key therapeutic class in their pipeline. Source: BioPharm Insight

3 Oncology Clinical Trials Oncology drugs are emerging as the new global market leaders For decades, cardiovascular drugs have held the top position in the global pharmaceutical market. However, the number of new oncology drugs entering the drug development pathway has been growing by approximately 30% annually for the last 10 years. If this trend continues, oncology drugs will replace statins as the top selling pharmaceutical by The changing face of oncology drug development As populations age and the incidence of cancer rises, the development of more effective cancer drugs is becoming more urgent. In response, researchers are moving in new directions. Specifically, the emergence of targeted anticancer therapies has ushered in a new era in cancer drug development. These drugs use molecular and genetic approaches to attack specific cancers on the cellular level which are creating a greater impact on endpoints such as overall response rate, time to progression and overall survival. In addition to targeted therapies, new sciences like genomics and proteomics may allow scientists to attack the underlying causes of cancer perhaps even to prevent cancer from occurring or retard its progression. These are the challenges and opportunities facing medical researchers today and why oncology is one of the fastest-growing areas of research in science today. ICON: Your partner for oncology clinical trial success Sound drug development expertise, therapeutic/portfolio management expertise, global field experience, a link to the medical community and a fully integrated plan are critical to the success of your oncology clinical trial. At ICON, we have made oncology drug development a core competency along with stellar project management. Oncology is currently ICON s fastest growing therapeutic area and a testament to our success in conducting oncology trials. To date, our experts have conducted over 450 Phase I-IV studies representing over 90,000 patients and 13,000 sites across 23 countries. Even though ICON is a large global company, we can customise our services to support smaller, locally managed projects. We currently have established relationships with over 500 oncology centres, including a strong network of Key Opinion Leaders in the U.S. and around the world, to provide you with a competitive advantage in supporting your global drug development efforts. ICON also has extensive experience with therapeutic agents such as conventional cytotoxics, hormonal and supportive care agents as well as a variety of innovative agents aimed at new targets, including vaccines, monoclonal antibodies, gene therapies and devices. Let ICON s global experience and expertise in oncology help you to achieve successful marketing authorisation and make crucial pipeline development decisions. ICON s Oncology Revenue Growth (in millions) $450 $400 $350 $300 $250 $200 $150 $100 $ ICON s Oncology Molecule Experience Molecule Indication Erbitux Colorectal Cancer Ixempra * Breast Cancer Pazopanib Renal Cell Cancinoma Sprycel Chronic Leukemia Sutent GI Stomal Tumour * FDA approved - October 2007

4 Oncology Solutions The ICON Oncology Solution ICON s Oncology Solution was expressly designed to expedite every aspect of a cancer drug trial through integration of critical services. It combines ICON s global experience in oncology trials with our expertise in tumour imaging, central laboratory, IVRS and CRF data, and provides sponsors with seasoned oncology project managers who act as a single point of contact across all clinical services for maximum efficiency. The goal of The Oncology Solution is to expedite the development of cancer therapies by making the development process more efficient at every level, and to enable sponsors to focus on critical endpoints. Stringent Quality Operational Performance and Manageability Successful Approvals and Reduced Time to Market The Oncology Solution: A Dedicated Cross Functional Model Projects conducted under The Oncology Solution will have a range of ICON services bundled under one common denominator: the Project Director. This key individual will be the single point of contact across all services and will oversee all cross functional activities and components of your clinical development program globally, regardless of where project contributors are located. The Project Director will also have the authority and responsibility to implement contingency plans across functional areas. Region CPMs CRAs US EU ROW Staff Oncology Experience ICON has invested in highly qualified personnel with experience in oncology drug development. Globally, this includes 439 Clinical Research Associates and 175 Project Directors/Managers with oncology experience. Total

5 The ICON Oncology Solution Project Director Project Start-up Integrated project and communication plan. Project Implementation Centralised, integrated, real-time project tracking. Data Analysis Expert blinded review of imaging and clinical data. Data Delivery Clean database for final transfer. Oncology TAG (Therapeutic Area Group) The in-depth therapeutic knowledge of ICON s TAG spans the entire development process, from preclinical strategy and the design and execution of proof of concept trials to regulatory approvals and post-submission marketplace acceptance. Core members of this group have extensive haematology and oncology drug development experience across several departments ensuring high quality oncology endpoints. ICON Oncology Experience - Past 5 Years Phase No. of Studies No. of Patients No. of Sites I 45 1, Site selection based on imaging capabilities and past performance. Development of patient recruitment plans. Single project manager co-ordinates activities across multiple services. IVR feeds of enrollment and of study events. DSMB support Integrated ecrf endpoint data. Integrated clinical CRF and imaging databases for trial sponsor or NDA/BLA submission. Medical writing and report generation. TAG members have worked on a wide variety of oncology programs and drug classes including anti-angiogenics, anti-metastatics, cytostatics, cytotoxics, hormonal treatments, gene therapies, hemopoietic growth factors, interferon, interleukin, monoclonal antibodies, new delivery systems, retinoids, vaccines and tumour biomarkers. They also have experience in various types of solid tumours including lung, breast, colorectal, pancreatic, ovarian, bladder, head and neck, cervix, renal cell, prostate and melanoma. The scope of responsibilities for Oncology TAG members includes: II 57 6, III 30 16,770 2,144 IV CLINICAL TOTAL ,060 3,284 Investigator meetings and site training incorporating image acquisition, tumour measurements and response criteria. Regulatory consulting and SPA development including protocol development, statistical plan, imaging charger and imaging manuals. Real-time image collection and quality assurance. Expert image review and tracking via MIRA TM and Oncology Image Review System. Innovative data management from OptICON, integrating Oracle-based CRF imaging and work flow management tool. Standard imaging reports for DSMB. Tables, listings & transfer formats pre-determined from tumour response data. Non-proprietary data formats enable archiving/mining of all imaging intellectual property facilitating knowledge transfer into future studies. Project feasibility (working in collaboration with established departments) Protocol development Protocol review and evaluation Product development planning Therapeutic experience and training Investigator/sponsor relationships Development of Academic Advisory Boards Liaison with opinion leader and collaborative groups Regulatory consulting and support Project management and oversight of project teams Clinical investigator interaction as needed to support patient recruitment and other operational issues Participation in country and site selection Medical monitoring Biostatistics - statistical design Endpoints adjudication Regulatory Consulting Consulting 42 NA NA Biometrics 63 6, Imaging ,345 4,846 IVRS 79 33,613 4,049 Other* 25 1, TOTAL ,628 12,852 *Includes stand-alone Quality Assurance, Regulatory Affairs, Laboratory Analysis, Medical Affairs and Medical Writing

6 Medical Imaging ICON Medical Imaging ICON Medical Imaging (IMI), a division of ICON plc, is an integral part of ICON s Oncology Solution. IMI provides medical imaging solutions for clinical trials to the pharmaceutical, biotech and medical device industries around the globe. Medical imaging can enhance and support clinical trials, and expand the methods used to acquire biological information thereby maximising your results. Medical imaging is playing an increasingly important role in clinical research and IMI is your guide to navigating the correct use and methodologies required. Our vast therapeutic and diagnostic experience includes, but is not limited to oncology, cardiology, neurology, rheumatology, diagnostic contrast imaging agents and medical devices with data from CT, MRI, SPECT, PET, Ultrasound, X-Ray and other imaging modalities. Complete Solutions Forged by more than 15 years of experience using imaging for drug development, IMI s full service solutions extend from protocol development, site selection/training, centralised data collection and analysis through submission to regulatory authorities. To date, IMI has submitted over 19 NDAs/BLAs to the FDA and EMEA. Of the 19 submissions, 11 of them were oncology focused. IMI manages and designs Independent Blinded Image Reviews providing qualitative and quantitative analyses. We have the flexibility to select from our own pool of sub-specialty reviewers or to choose from pre-eminent experts globally to ensure the correct match of independent readers to your specific protocol. Client Enabling Technologies MIRA is IMI s complete image management and review system providing 24-7 access to patient tracking, study reports, and medical images allowing study teams unparalleled access to critical information. MIRA also enables our radiologists and clinicians to perform remote read sessions and provides a complete, secure, audit trail of every step in the process. IMI has created an Oncology Review System that uses standard response assessment criteria to reduce the startup of your trial to two weeks. This validated, 21 CRF Part 11 Compliant System permits efficient image data processing with a minimum investment in setup time. IMI s Oncology Image Review System consists of a completely validated package including: An Independent Image Review Charter A RECIST based ecrf linked directly to our image management and analysis system 24/7 live reporting from the system to keep the team informed of each subject s status A comprehensive, image enabled, outcomes based database for internal use or delivery to regulatory authorities All components have been completely validated and comply with GCP and 21 CRF Part 11, including complete audit trail tracking. The system has been sent to FDA and currently is in use for recent oncology submissions. The system allows protocol specific configuration and allowing IMI to begin reading within two (2) weeks. No other competitor offers these components, in this time frame, with this level of quality. Stringent Quality Quality drives the ICON Medical Imaging process, from data collection to the delivery of blinded image review analyses. Each set of data that comes through IMI encounters the most rigorous quality practices in the industry. Dedicated quality assurance personnel oversee compliance to project specific protocols, ICON Medical Imaging SOPs and strict regulatory standards. Secure servers create backup images on- and off-site. We design, create and validate electronic imaging CRFs to collect the image analyses with logic checks built in to maximise efficiency. By employing rigorous quality checks throughout the process, IMI ensures the highest level of data integrity. Excellence... just ask our Clients Large, Global Phase III Oncology Trial Starting with the bid defence, ICON brought the right team. Although the other two bidding CRO's were impressive in their own right, the ICON personnel acted and responded like a team. This more than anything else separated them from the other two. Since that time, the ICON clinical team has performed admirably on a large, global Phase III Programme consisting of three distinct protocols. The programme covers 33 countries, and will enrol over 3000 patients. They achieve targets, they are pro-active, they demonstrate a can-do attitude, and they are responsive to changing client needs. ICON has become fully integrated into the project team. Client/ICON affiliations seem secondary to being a member of the programme team. I'm confident we made the right decision in selecting ICON for this programme. James G. Hunt Study Delivery Leader AstraZeneca Pharmaceuticals

7 ICON plc Corporate Headquarters South County Business Park Leopardstown Dublin 18 Ireland T: F: E: ICON Clinical Research US 212 Church Road North Wales PA T: F: E:

Strategy Planning Management Execution Analysis

Strategy Planning Management Execution Analysis Leading the way Strategy Planning Execution Analysis 1 Excellence in Delivery ICON is a division of ICON plc. It specializes in the planning management, execution, and analysis of Phase IIb IV clinical

More information

Clinical Trial Operations

Clinical Trial Operations Contract Research and Consulting Organisation Consulting Clinical Trial Operations Training Your partner for CLINically remarkable results We are a leading Polish company specializing in clinical research

More information

An information platform that delivers clinical studies better, faster, safer and more cost effectively

An information platform that delivers clinical studies better, faster, safer and more cost effectively An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites

More information

Job Profile Clinical Research Associate I/II (CRA)

Job Profile Clinical Research Associate I/II (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

Fact Sheet: Molecular Imaging and Cancer

Fact Sheet: Molecular Imaging and Cancer Fact Sheet: Molecular Imaging and Cancer Cancer causes one in every four deaths in the United States, second only to heart disease. According to the American Cancer Society, an estimated 1.48 million new

More information

Execution in Clinical Research

Execution in Clinical Research TM TM Execution in Clinical Research Execution - a key driver for success Medpace, long known for its excellence in conducting Phase I-IV studies on a global platform, is particularly noted for its therapeutic

More information

Needs, Providing Solutions

Needs, Providing Solutions Identifying Needs, Providing Solutions 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved

More information

Adjudication in Oncology Trials: A Concept Whose Time Has Come

Adjudication in Oncology Trials: A Concept Whose Time Has Come Adjudication in Oncology Trials: A Concept Whose Time Has Come By WorldCare Clinical: Richard Walovitch, PhD, Chief Medical Officer, Asli Memisoglu, ScD, Director of Biostatistics and Data Management,

More information

Infoset builds software and services to advantage business operations and improve patient s life

Infoset builds software and services to advantage business operations and improve patient s life Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data

More information

TABLE OF CONTENTS. Introduction...1. Chapter1 AdvancesinTreatment...2. Chapter2 MedicinesinDevelopment...11. Chapter3 ValueandSpending...

TABLE OF CONTENTS. Introduction...1. Chapter1 AdvancesinTreatment...2. Chapter2 MedicinesinDevelopment...11. Chapter3 ValueandSpending... CANCER TABLE OF CONTENTS Introduction...1 Chapter1 AdvancesinTreatment...2 Chapter2 MedicinesinDevelopment......11 Chapter3 ValueandSpending......15 Chapter4 Conclusion...22 INTRODUCTION Researchers and

More information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

Biological Therapies for Cancer

Biological Therapies for Cancer Biological Therapies for Cancer Key Points Biological therapies use the body's immune system to fight cancer or to lessen the side effects that may be caused by some cancer treatments. Biological therapies

More information

www.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS

www.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Global clinical trial solutions. Real-world results. Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Clinical Trial Management Clinical Data Management www.bioclinica.com

More information

2014 Report: biotechnologies in the Italian pharmaceutical sector

2014 Report: biotechnologies in the Italian pharmaceutical sector 2014 Report: biotechnologies in the Italian pharmaceutical sector In collaboration with Assobiotec Executive summary Executive summary Executive summary Biotechnologies have always influenced all spheres

More information

Groundbreaking Collaborative Clinical Trial Launched

Groundbreaking Collaborative Clinical Trial Launched Groundbreaking Collaborative Clinical Trial Launched For immediate release Media Contacts: June 16, 2014 Richard Folkers Alison Hendrie 9:00 a.m., EDT Foundation for the NIH Rubenstein Communications (301)

More information

Meeting Priorities of Biotech & Small Pharma Companies

Meeting Priorities of Biotech & Small Pharma Companies Meeting Priorities of Biotech & Small Pharma Companies Dr. Andreas Orfanos, MBBCH,FFPM,MBA Thrasos Therapeutics Inc. Vice President Clinical Research & Development 28 Oct 2015 Montreal Technoparc Private,

More information

David Feltl, M.D., Ph.D., MBA. Structure and organization of cancer care in the Czech Republic. Assessment of outputs and outcomes.

David Feltl, M.D., Ph.D., MBA. Structure and organization of cancer care in the Czech Republic. Assessment of outputs and outcomes. David Feltl, M.D., Ph.D., MBA Structure and organization of cancer care in the Czech Republic. Assessment of outputs and outcomes. Contents Cancer epidemiology in the Czech Republic National oncology program

More information

Equity markets Major advances in cancer therapeutics 18 August 2015

Equity markets Major advances in cancer therapeutics 18 August 2015 Major advances in cancer therapeutics 18 August 2015 CIO WM Research Jerome Brimeyer, Equity Sector Strategist, jerome.brimeyer@ubs.com Our cancer therapeutics investment theme recommends companies that

More information

Ending cancer. Together.

Ending cancer. Together. Ending cancer. Together. Making History by Being First To achieve something as big and bold as ending cancer requires the courage to be first and a willingness to partner with others. At the Robert W.

More information

Interactive Response Technologies

Interactive Response Technologies Interactive Response Technologies Increasing accuracy and efficiency in clinical trials To increase the accuracy and efficiency of conducting your global clinical trials, ICON s Interactive Response Technologies

More information

Sales Force Effectiveness in Pharmaceuticals

Sales Force Effectiveness in Pharmaceuticals Sales Force Effectiveness in Pharmaceuticals Targeted Sales Models such as Enhanced Key Account Management (KAM) and Closed-Loop Marketing (CLM) Strategies Drives Sales Force Efficiency GBI Research Report

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

The Art of Auditing Bioanalytical Laboratories

The Art of Auditing Bioanalytical Laboratories Sponsor Audits of Bioanalytical Laboratories One of the critical tasks for a Good Laboratory Practices (GLP) nonclinical laboratory study or Clinical Trial team is choosing a bioanalytical laboratory vendor

More information

CURRICULUM VITAE. Name: Florencia Licastro Job Title: Director, Training and Development. Summary of experience

CURRICULUM VITAE. Name: Florencia Licastro Job Title: Director, Training and Development. Summary of experience CURRICULUM VITAE Name: Florencia Licastro Job Title: Director, Training and Development Summary of experience Over 11 years working in Clinical Research in a large CRO, starting as Clinical Research Associate,

More information

Small-Cell Lung Cancer Global Clinical Trials Review, H2, 2015

Small-Cell Lung Cancer Global Clinical Trials Review, H2, 2015 Brochure More information from http://www.researchandmarkets.com/reports/3398017/ Small-Cell Lung Cancer Global Clinical Trials Review, H2, 2015 Description: Small-Cell Lung Cancer Global Clinical Trials

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure

More information

Pennino Corporation TECHNOLOGY TO IMPROVE LIFE

Pennino Corporation TECHNOLOGY TO IMPROVE LIFE Pennino Corporation TECHNOLOGY TO IMPROVE LIFE Agenda The Opportunity Highlights Corporate Profile NYU Relationship Obesity and Diabetes Graphics and Facts Next Stage of Development Efficacy and Safety

More information

A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee

A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee A Second Opinion for Subjective Endpoints: The Case for an Endpoint Assessment Committee Introduction to EAC The FDA s recent guidance on imaging standards and increased frequency of requests for a Blinded

More information

Waiver to Allow Participation in a Food and Drug Administration Advisory Committee

Waiver to Allow Participation in a Food and Drug Administration Advisory Committee DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring MD 20993 Waiver to Allow Participation in a Food and Drug Administration Advisory Committee DATE:

More information

Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008

Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008 A Service of Indigo Research A Cipher www.indigoresearch.com Global CRO Market 2005- $15 Billion Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008 Published April 2008 CRO

More information

My Big Data experience getting my feet wet in the puddle and still treading water 2 years later 28 th June 2013. Rob Walls Healthcare Data Analytics

My Big Data experience getting my feet wet in the puddle and still treading water 2 years later 28 th June 2013. Rob Walls Healthcare Data Analytics My Big Data experience getting my feet wet in the puddle and still treading water 2 years later 28 th June 2013 Rob Walls Healthcare Data Analytics Abstract "Big Data" - Electronic Health Records (EHR)

More information

Plan and manage clinical trials with clarity and confidence

Plan and manage clinical trials with clarity and confidence Plan and manage clinical trials with clarity and confidence Accurately identify opportunities and avoid obstacles throughout the clinical trial process with IMS Health Clinical Trial Optimization Solutions

More information

Shifting paths of pharmaceutical innovation: Implications for the global pharmaceutical industry

Shifting paths of pharmaceutical innovation: Implications for the global pharmaceutical industry Shifting paths of pharmaceutical innovation: Implications for the global pharmaceutical industry Tariq Sadat PhD Candidate School of Economics, Finance and Marketing, RMIT University, Australia Roslyn

More information

We set things in motion and keep them moving. Metronomia Clinical Research Services

We set things in motion and keep them moving. Metronomia Clinical Research Services We set things in motion and keep them moving Metronomia Clinical Research Services Our customers love the fact that we keep up with their individual tempos. Dorothea Wessiepe, Director Biostatistics Metronomia:

More information

The Global Biotech Industry: Challenges & Opportunities Michael S. Rosen Rosen Bioscience Strategies

The Global Biotech Industry: Challenges & Opportunities Michael S. Rosen Rosen Bioscience Strategies The Global Biotech Industry: Challenges & Opportunities Michael S. Rosen Rosen Bioscience Strategies Greetings from Chicago! Beaches Yes! Pharma Beginnings! Bogota 1974 Selling Drugs in Colombia Global

More information

Global Non-Small Cell Lung Cancer Therapeutics Market 2015-2019

Global Non-Small Cell Lung Cancer Therapeutics Market 2015-2019 Brochure More information from http://www.researchandmarkets.com/reports/3453273/ Global Non-Small Cell Lung Cancer Therapeutics Market 2015-2019 Description: About non-small cell lung cancer therapeutics

More information

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical

More information

Biotherapeutic Medicines

Biotherapeutic Medicines International Federation of Pharmaceutical Manufacturers & Associations Biotherapeutic Medicines Grasping the New Generation of Treatments Biotherapeutic medicines are an integral and valuable part of

More information

THE BIOTECH & PHARMACEUTICAL INDUSTRY

THE BIOTECH & PHARMACEUTICAL INDUSTRY THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues

More information

Syndax Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Business Update Following IPO

Syndax Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Business Update Following IPO Syndax Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Business Update Following IPO ENCORE 601 Phase 1b dose escalation has been completed and safety confirmation has commenced

More information

Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference

Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference Two New Clinical Programs and Significant Expansion of Cancer Pipeline Planned for 2004 SOUTH SAN FRANCISCO, Calif., Jan. 13 /PRNewswire-FirstCall/

More information

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital Position Description POSITION TITLE Project Manager TYPE OF EMPLOYMENT Full-time or part-time upto 1.0 FTE, 4 year fix term REPORTING TO a) Principal Investigator DIVISION Department of Cardiology COMPANY

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

Next Generation Sequencing Informatics Markets

Next Generation Sequencing Informatics Markets Next Generation Sequencing Informatics Markets Greg Caressi SVP Healthcare & Life Sciences November, 2014 Personalization, Communication, Decentralization, Collaboration From... One Size Fits All APPROACH...To

More information

Technology and Expertise Add Operational Value to Medical Device Trials

Technology and Expertise Add Operational Value to Medical Device Trials Technology and Expertise Add Operational Value to Medical Device Trials Copyright 2015 Medidata Solutions. Medidata Solutions and other trademarks reserved in the US and globally. Medidata and other marks

More information

Cancer Clinical Trials: In-Depth Information

Cancer Clinical Trials: In-Depth Information Cancer Clinical Trials: In-Depth Information The Drug Development and Approval Process 1. Early research and preclinical testing 2. IND application filed with FDA 3. Clinical trials (phases 1, 2, and 3)

More information

The Promise and Challenge of Adaptive Design in Oncology Trials

The Promise and Challenge of Adaptive Design in Oncology Trials THE POWER OFx Experts. Experience. Execution. The Promise and Challenge of Adaptive Design in Oncology Trials Clinical oncology trials are more complex and time consuming than those in any other therapeutic

More information

Waiver to Allow Participation in a Food and Drug Administration Advisory Committee

Waiver to Allow Participation in a Food and Drug Administration Advisory Committee DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring MD 20993 Waiver to Allow Participation in a Food and Drug Administration Advisory Committee DATE:

More information

Overcoming cancer with research Vienna 15 th -17 th May, 2008. Session 3: Established therapeutic compounds

Overcoming cancer with research Vienna 15 th -17 th May, 2008. Session 3: Established therapeutic compounds Overcoming cancer with research Vienna 15 th -17 th May, 2008 Session 3: Established therapeutic compounds Introduction Randomized clinical trials: bedrock of progress in children with cancer in the last

More information

1 The Clinical Research Coordinator (CRC)... 1

1 The Clinical Research Coordinator (CRC)... 1 TABLE OF CONTENTS Acknowledgments... xi Introduction... xiii 1 The Clinical Research Coordinator (CRC)... 1 Background and Training of the CRC...1 Personality and Skills... 2 Where Do CRCs Work?... 2 CRC

More information

U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade. N8B7-52 December 2010

U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade. N8B7-52 December 2010 U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade December 2010 Table of Contents Notes on Methodology 8 Market Introduction and Segmentation Introduction

More information

Data-management and Biostatistics

Data-management and Biostatistics Data-management and Biostatistics OnQ Data prides itself in being able to offer a cost-effective flexible service that result in the hassle-free generation of clean, high quality scientific data in the

More information

Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022

Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022 Brochure More information from http://www.researchandmarkets.com/reports/2228475/ Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022 Description: Avastin (Renal Cell Carcinoma) Analysis and

More information

There must be an appropriate administrative structure for each residency program.

There must be an appropriate administrative structure for each residency program. Specific Standards of Accreditation for Residency Programs in Radiation Oncology 2015 VERSION 3.0 INTRODUCTION The purpose of this document is to provide program directors and surveyors with an interpretation

More information

THE ROLE OF BIG DATA IN HEALTH AND BIOMEDICAL RESEARCH. John Quackenbush Dana-Farber Cancer Institute Harvard School of Public Health

THE ROLE OF BIG DATA IN HEALTH AND BIOMEDICAL RESEARCH. John Quackenbush Dana-Farber Cancer Institute Harvard School of Public Health THE ROLE OF BIG DATA IN HEALTH AND BIOMEDICAL RESEARCH John Quackenbush Dana-Farber Cancer Institute Harvard School of Public Health CONFIDENTIAL Background and Disclosures Professor of Biostatistics and

More information

MEDIA RELEASE. Embargoed until 10:00 9 th November 2014

MEDIA RELEASE. Embargoed until 10:00 9 th November 2014 MEDIA RELEASE Embargoed until 10:00 9 th November 2014 National Ovarian Cancer Research Strategy Launch For the First Time Critical Pathways Mapped to Better Care and Survival Rates for One of Australia

More information

Operational aspects of a clinical trial

Operational aspects of a clinical trial Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration

More information

A clinical research organization

A clinical research organization A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced

More information

Biological Therapies for Cancer: Questions and Answers. Key Points

Biological Therapies for Cancer: Questions and Answers. Key Points CANCER FACTS N a t i o n a l C a n c e r I n s t i t u t e N a t i o n a l I n s t i t u t e s o f H e a l t h D e p a r t m e n t o f H e a l t h a n d H u m a n S e r v i c e s Biological Therapies for

More information

A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT

A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT Accelovance 2275 Research Boulevard, Suite 700 Rockville, MD 20850, United States Phone: +1.240.238.4900 Fax: +1.240.238.4901 Internet: www.accelovance.com email: gsmith@accelovance.com Contact Person:

More information

Future Oncology: Technology, Products, Market and Service Opportunities

Future Oncology: Technology, Products, Market and Service Opportunities Brochure More information from http://www.researchandmarkets.com/reports/296370/ Future Oncology: Technology, Products, Market and Service Opportunities Description: Future Oncology is an analytical newsletter

More information

FDA grants Roche s cancer immunotherapy Tecentriq (atezolizumab) accelerated approval for people with a specific type of advanced bladder cancer

FDA grants Roche s cancer immunotherapy Tecentriq (atezolizumab) accelerated approval for people with a specific type of advanced bladder cancer Media Release Basel, 19 May 2016 FDA grants Roche s cancer immunotherapy Tecentriq (atezolizumab) accelerated approval for people with a specific type of advanced bladder cancer First and only anti-pd-l1

More information

CANCER LEADERSHIP COUNCIL

CANCER LEADERSHIP COUNCIL CANCER LEADERSHIP COUNCIL A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS ADDRESSING PUBLIC POLICY ISSUES IN CANCER March 27, 2015 The Honorable Fred Upton Chairman, Committee on Energy & Commerce

More information

A Letter from MabVax Therapeutics President and Chief Executive Officer

A Letter from MabVax Therapeutics President and Chief Executive Officer A Letter from MabVax Therapeutics President and Chief Executive Officer Dear Fellow Stockholder: You have invested in MabVax Therapeutics because you share our passion for finding new therapies for the

More information

To know more about Pharmacovigilance and Clinical Trials Data Management

To know more about Pharmacovigilance and Clinical Trials Data Management To know more about Pharmacovigilance and Clinical Trials Data Management 1. What is Pharmacovigilance? Pharmacovigilance (PV) is the pharmacological science related to the detection, assessment, understanding

More information

Breast Cancer Drug Discoveries: What the Future Holds

Breast Cancer Drug Discoveries: What the Future Holds Brochure More information from http://www.researchandmarkets.com/reports/679630/ Breast Cancer Drug Discoveries: What the Future Holds Description: In 2010, almost 50% of breast cancer sales were due to

More information

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013 Achieving Regulatory Success: Areas of focus for biotechnology companies Michael J. Schlosser, PhD, DABT April 21, 2013 Regulatory Success Outline Regulatory Initiatives Regulatory Science Pre-Regulatory

More information

Number. Source: Vital Records, M CDPH

Number. Source: Vital Records, M CDPH Epidemiology of Cancer in Department of Public Health Revised April 212 Introduction The general public is very concerned about cancer in the community. Many residents believe that cancer rates are high

More information

Clinical Data Management Overview

Clinical Data Management Overview The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

The Future of R&D Outsourcing

The Future of R&D Outsourcing OUTSOURCING The Future of R&D Outsourcing Investigating development hurdles, key challenges & strategies to optimize CRO relationships By Alison Sahoo Alison Sahoo Alison Sahoo is a pharmaceutical industry

More information

Issues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit?

Issues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit? ELLEN PURÉ, Ph.D. Issues Does the academe have as a goal or an obligation, the development of its discoveries for human benefit? Can the academic review process support individual career development in

More information

Clinical Development Success Rates Biomedtracker Pharma intelligence

Clinical Development Success Rates Biomedtracker Pharma intelligence Clinical Development Success Rates 2006-2015 Biomedtracker Pharma intelligence June 2016 About BIO BIO is the world s largest trade association representing biotechnology companies, academic institutions,

More information

What We Are..! www.ardent-cro.com

What We Are..! www.ardent-cro.com Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: ardent@ardent-cro.com Web: What We Are..! Ardent Clinical Research Services is

More information

ORPHAN DRUG. ORPHAN DRUG & RARE DISEASE DEVELOPMENT: Understanding the U.S. and European Regulatory Landscape & RARE DISEASE DEVELOPMENT

ORPHAN DRUG. ORPHAN DRUG & RARE DISEASE DEVELOPMENT: Understanding the U.S. and European Regulatory Landscape & RARE DISEASE DEVELOPMENT : Abstract Today, more than ever, researchers are focused on providing care for the approximately 7,000 rare diseases that may have been overlooked in the past due to the challenges of conducting clinical

More information

BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE

BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE Jean Toth-Allen, Ph.D. Biophysicist Office of Good Clinical Practice Office of the Commissioner May 14, 2012 1 Overview I. Background why we are

More information

Pfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology. November 17, 2014

Pfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology. November 17, 2014 Pfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology November 17, 2014 Forward-looking statements Our discussions during this conference call will

More information

Key considerations for outsourcing late phase clinical research

Key considerations for outsourcing late phase clinical research Key considerations for outsourcing late phase clinical research Alan Nelson (on behalf of Van Zyl Engelbrecht) Senior Project Director at UBC: An Express Script Company Layout of presentation My presentation

More information

The New Kid on the Block for Advanced Renal Cell Carcinoma

The New Kid on the Block for Advanced Renal Cell Carcinoma The New Kid on the Block for Advanced Renal Cell Carcinoma Wyeth Pharmaceuticals recently launched Torisel (temsirolimus), a targeted, first-in-class mtor inhibitor. This new treatment for metastatic renal

More information

FROM MOLECULES TO MEDICINE: HOW ARE NEW DRUGS & THERAPIES DEVELOPED?

FROM MOLECULES TO MEDICINE: HOW ARE NEW DRUGS & THERAPIES DEVELOPED? FROM MOLECULES TO MEDICINE: HOW ARE NEW DRUGS & THERAPIES DEVELOPED? FROM MOLECULES TO MEDICINE: HOW ARE NEW DRUGS & THERAPIES DEVELOPED? Introduction This Global Genes Toolkit will provide you with an

More information

OPKO Health to Acquire Bio-Reference Laboratories

OPKO Health to Acquire Bio-Reference Laboratories OPKO Health to Acquire Bio-Reference Laboratories - Complementary in-depth expertise in diagnostics business with state of the art experience in use of genomic data for personalized therapy - Acquisition

More information

Why Monitoring Is More Than Just SDV

Why Monitoring Is More Than Just SDV Why Monitoring Is More Than Just SDV Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners. Copyright 2013 Medidata

More information

Theories on Metastasis: Innovative Thinking An Advocacy Perspective

Theories on Metastasis: Innovative Thinking An Advocacy Perspective Theories on Metastasis: Innovative Thinking An Advocacy Perspective Project LEAD Workshop NBCC Annual Advocacy Conference 2011 Musa Mayer AdvancedBC.org 1 The Big Question If we want to end death from

More information

Even we will get to use your product someday. Enough reason for us to deliver.

Even we will get to use your product someday. Enough reason for us to deliver. Even we will get to use your product someday. Enough reason for us to deliver. ClinInvent: Putting our heart and soul behind the research. At ClinInvent, when we talk about clinical research it s not just

More information

There are 2 types of clinical trials that are of interest to the. The Clinical Trials Network of the Society of Nuclear Medicine

There are 2 types of clinical trials that are of interest to the. The Clinical Trials Network of the Society of Nuclear Medicine The Clinical Trials Network of the Society of Nuclear Medicine Michael M. Graham, PhD, MD The Clinical Trials Network of the Society of Nuclear Medicine was formed to provide quality assurance of both

More information

A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations

A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations Ce3, Inc. and Insight Genetics, Inc. Oncology Forum July 15, 2015 Agenda Introductions Definitions Regulations

More information

Join our scientific talent community

Join our scientific talent community Join our scientific talent community There has never been a better time to be a part of Janssen Research & Development. We are at the forefront of healthcare leading, evolving and transforming it into

More information

Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. Response from Cancer Research UK to the Commission August 2010

Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. Response from Cancer Research UK to the Commission August 2010 Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices Response from Cancer Research UK to the Commission August 2010 1. Cancer Research UK (CR-UK) 1 is leading the world in finding

More information

The Commercialization of Technology Concepts into Medical Products

The Commercialization of Technology Concepts into Medical Products The Commercialization of Technology Concepts into Medical Products Kevin J. Scanlon, Ph.D. New Zealand 2006 International BioScience Overview Pharmaceutical Industry Biotechnology Startups Investment Community

More information

EMERGING MARKETS: NAVIGATING THE PATH TO CONDUCT SUCCESSFUL CLINICAL TRIALS IN CHINA

EMERGING MARKETS: NAVIGATING THE PATH TO CONDUCT SUCCESSFUL CLINICAL TRIALS IN CHINA EMERGING MARKETS: NAVIGATING THE PATH TO CONDUCT SUCCESSFUL CLINICAL TRIALS IN CHINA As industry pressure to conduct successful global clinical trials on time and on budget continue, tapping emerging global

More information

Patient Centric Monitoring Methodology

Patient Centric Monitoring Methodology Patient Centric Monitoring Methodology The ICON approach to risk based monitoring in clinical trials An ICON White Paper Introduction The pharmaceutical and CRO industries are undergoing a radical shift

More information

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series Part II: Later-Stage Development: Ensuring Compliance During Clinical i l Trials Process Driven Compliance for a Competitive Advantage Webinar Series 29 September 2010 Process Driven Compliance Webinar

More information

Overview of Phase 1 Oncology Trials of Biologic Therapeutics

Overview of Phase 1 Oncology Trials of Biologic Therapeutics Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of

More information

Associate Group Director, Regulatory Intelligence & Policy

Associate Group Director, Regulatory Intelligence & Policy Date: 06/24/16 Associate Group Director, Regulatory Intelligence & Policy Job ID: 2974410847 Job Function Project Management Regulatory Affairs Location United States - District of Columbia Washington

More information

DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS

DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS Jeanne Ashton, Executive Director, Data Management Introduction Clinical data management and data quality are key strategic assets of large pharmaceutical companies

More information

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient

More information

Graduation Day. Congratulations You re an Information Manager! Paula Brown Stafford President, Clinical Development

Graduation Day. Congratulations You re an Information Manager! Paula Brown Stafford President, Clinical Development Graduation Day Congratulations You re an Information Manager! Paula Brown Stafford President, Clinical Development Welcome Information Management Graduates Who we were Managing data way back when Who we

More information

shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success

shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success Proven success and contacts. Not just talk. TCG is a

More information

ORACLE CLINICAL. Globalization. Flexibility. Efficiency. Competition ORACLE DATA SHEET OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION

ORACLE CLINICAL. Globalization. Flexibility. Efficiency. Competition ORACLE DATA SHEET OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION ORACLE CLINICAL OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION Smoothly transition from paper to EDC trials Annotated CRFs provides an intuitive means of creating submission-ready annotations Improved

More information

PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES

PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES PPD Laboratories provides world-class scientific expertise with state-of-the-art technologies supported by a commitment

More information